Assists the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work, standard operating procedures, and GCP regulatory requirements
Assists Clinical Project Manager in site management activities which could include review of monitoring reports, tracking of site visits, enrollment logs, expenses, communication with CRAs, vendors, or sites, and other activities as assigned
Assists Clinical Project Manager in clinical study site start-up activities and regulatory documentation reconciliation
Organizes and prepares study documents related to study tracking and reporting and maintains documents in electronic Trial Master File within established guidelines
Assists with periodic review of study files for completeness
Performs other duties as assigned
In-depth, working knowledge of ICH E6 GCP Guidelines and FDA regulations for essential document requirements to support clinical studies
Demonstrated ability to meet deadlines and to multi-task effectively
Excellent written and verbal communication skills including good command of English language
Excellent computer skills (Windows, Outlook, MS-Excel, MS-Word, Adobe Standard or Professional)
Strong problem solving and detail orientation skills
Ability to interact well with diverse team members
Displays ability to independently solve routine problems following standard policies/procedures
BA or BS (or equivalent experience)
At least 2 years’ experience in clinical research, clinical project administration, or similar relevant experience
Cardinal Health is an Equal Opportunity/Affirmative Action employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex,
sexual orientation, gender identity, national origin, disability, or protected veteran status.
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